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Abstract
According to 21 Code of Federal Regulation (CFR) Part 211, OTC manufacturers must establish and follow current good manufacturing practices (cGMP) to produce quality products while meeting regulatory standards. The warning letters issued by the U.S. Food and Drug Administration (FDA) reveals quality inadequacies that may impact the safety and effectiveness of these products. This study provides an analysis of warning letters and cited violations from FY2015 to FY 2019 to identify the most common areas of quality issues and to understand the FDA’s current thinking on regulatory expectations. Violations relating to product and process controls significantly increased, while violations relating to labeling decreased over the years. Despite these changes in violation numbers, the number of violations increased in most categories, thus projecting the continual increase of quality inadequacies in the OTC industry.